TY - JOUR
T1 - Differences in Quality of Life between Bendamustine-Rituximab and R-CHOP/R-CVP in Patients with Previously Untreated Advanced Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma
AU - Burke, John M.
AU - Van Der Jagt, Richard H.C.
AU - Kahl, Brad S.
AU - Wood, Peter
AU - Hawkins, Tim E.
AU - Macdonald, David
AU - Hertzberg, Mark
AU - Simpson, David
AU - Craig, Michael
AU - Kolibaba, Kathryn
AU - Issa, Samar
AU - Munteanu, Mihaela
AU - Victor, Timothy W.
AU - Flinn, Ian W.
N1 - Funding Information:
This research was sponsored and conducted by Teva Branded Pharmaceutical Products R&D, Inc, Frazer, PA. Funding for editorial support was provided by Teva Branded Pharmaceutical Products R&D, Inc, Frazer, PA, to The Curry Rockefeller Group, LLC, Tarrytown, NY. A special thank you goes to all investigators, study and clinical research staff, and patients and their families for participating or being involved in this study. A complete list of the BRIGHT Study Investigators can be found in the online version (at http://dx.doi.org/10.1016/j.clml.2016.01.001 ).
Funding Information:
J Burke has served as a consultant or on the scientific advisory board of Seattle Genetics, Dr. Reddy's Laboratories, Incyte, Millennium, and Janssen; conducted clinical research projects funded, in whole or in part, by Genentech. R van der Jagt has served as a consultant or on the scientific advisory board of Lundbeck and Teva; received honoraria from Roche, Celgene, and Novartis; conducted clinical research projects funded, in whole or in part, by Lundbeck, Roche, Teva, Celgene, and CTI. B Kahl has served as a consultant or on the scientific advisory board of Genentech and Teva; conducted clinical research projects funded, in whole or in part, by Genentech. D MacDonald has served as a consultant or on the scientific advisory board of Lundbeck Canada and Roche. K Kolibaba has conducted clinical research projects funded, in whole or in part, by Pharmacyclics. M Munteanu is an employee of and has stock ownership in Teva. I Flinn has conducted clinical research projects funded, in whole or in part, by Teva and Genentech. All other authors state that they have no conflicts of interest.
Publisher Copyright:
© 2016 The Authors.
PY - 2016/4/1
Y1 - 2016/4/1
N2 - Background We previously reported results of the phase III, randomized, noninferiority trial comparing bendamustine-rituximab (BR) with standard R-CHOP (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone)/R-CVP (rituximab/cyclophosphamide/vincristine/prednisone) in previously untreated advanced indolent non-Hodgkin and mantle cell lymphomas. Here we report health-related quality of life (HRQOL) results from the trial. Methods HRQOL, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), was a secondary end point. Differences between group means in global health status (GHS), 5-item functioning, and 9 symptoms/single-item measures at week 1 of cycle 1 and end-of- cycles 3 and 6 were examined using the screening (baseline) score as a covariate in analysis of covariance. Results Overall EORTC QLQ-C30 compliance was 75.2%, 89.5%, and 89.9% at week 1 of cycle 1 and end-of-cycles 3 and 6, respectively. Patients treated with BR reported improvements in Cognitive Functioning, Physical Functioning, Social Functioning, Emotional Functioning, and GHS as well as reduction in dyspnea, constipation, and fatigue at some, but not all, time points. Patients treated with standard therapy reported less nausea/vomiting at one time point. Conclusion Compared with patients treated with standard therapy, patients treated with BR reported better quality of life in several areas.
AB - Background We previously reported results of the phase III, randomized, noninferiority trial comparing bendamustine-rituximab (BR) with standard R-CHOP (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone)/R-CVP (rituximab/cyclophosphamide/vincristine/prednisone) in previously untreated advanced indolent non-Hodgkin and mantle cell lymphomas. Here we report health-related quality of life (HRQOL) results from the trial. Methods HRQOL, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), was a secondary end point. Differences between group means in global health status (GHS), 5-item functioning, and 9 symptoms/single-item measures at week 1 of cycle 1 and end-of- cycles 3 and 6 were examined using the screening (baseline) score as a covariate in analysis of covariance. Results Overall EORTC QLQ-C30 compliance was 75.2%, 89.5%, and 89.9% at week 1 of cycle 1 and end-of-cycles 3 and 6, respectively. Patients treated with BR reported improvements in Cognitive Functioning, Physical Functioning, Social Functioning, Emotional Functioning, and GHS as well as reduction in dyspnea, constipation, and fatigue at some, but not all, time points. Patients treated with standard therapy reported less nausea/vomiting at one time point. Conclusion Compared with patients treated with standard therapy, patients treated with BR reported better quality of life in several areas.
KW - BRIGHT trial
KW - EORTC QLQ-C30
KW - First-line therapy
KW - Patient-reported outcomes
KW - Phase 3
UR - http://www.scopus.com/inward/record.url?scp=84962287377&partnerID=8YFLogxK
U2 - 10.1016/j.clml.2016.01.001
DO - 10.1016/j.clml.2016.01.001
M3 - Article
C2 - 26875824
AN - SCOPUS:84962287377
SN - 2152-2650
VL - 16
SP - 182-190.e1
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 4
ER -